Amidst all the fury over the Bush stem cell funding restrictions, every once in a while stories would appear indicating that the field was really being stifled not by funding problems–I’ll say–ESCR received more than $2 billion in private/public funding during the Bush years–but patent problems. And indeed, embryonic stem cells–as distinguished from the methods of deriving them–should not be patentable since they are not human inventions.
Now a court has ruled that cancer genes are not patentable–and for the same reasons. From the story:
In a ruling with potentially far-reaching implications for the patenting of human genes, a judge on Monday struck down a company’s patents on two genes linked to an increased risk of breast and ovarian cancer. The decision by U.S. District Judge Robert Sweet challenging whether anyone can hold patents on human genes was expected to have broad implications for the biotechnology industry and genetics-based medical research. Sweet said he invalidated the patents because DNA’s existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body nor the information it encodes.
The point is to prevent companies from monopolizing regenerative medical capabilities:
Last March, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics Inc., based in Salt Lake City, the University of Utah Research Foundation and the U.S. Patent and Trademark Office.The ACLU and the patent foundation said Myriad’s refusal to license the patents broadly has meant that women who fear they may be at risk of breast or ovarian cancers are prevented from having anyone but Myriad look at the genes in question.
Myriad attorney Brian Poissant declined to comment. At a hearing before Sweet last month, Poissant said disallowing the patents would wreck the foundation of the biotechnology industry.
Chris Hansen, one of the lawyers who argued the case for the ACLU, said the ruling provides a “strong advance for women’s health and for science.” He said the ruling, if upheld, would threaten many of the patents held on approximately 20 percent of the human genome. “In our view, it would enormously increase women’s opportunities to receive testing and diagnoses and would liberate research opportunities for researchers all over the country,” Hansen said…
Mary-Claire King, the University of Washington scientist who discovered the first breast cancer predisposition gene, BRCA-1, while at the University of California at Berkeley in 1990, called the ruling “very good news for women who are potential carriers” of cancer genes and their families. “It will open the door to truly competitive testing. It will allow the science to drive the field instead of the monopolistic approach that has dominated,” she said. Patenting a gene “makes no sense,” King said. “It’s like patenting one’s thumb.”
I can’t believe I am on the same side as the ACLU, but the group is right: Body parts–which are not human inventions–should not be subject to private ownership. I applaud this decision and hope it sticks.
March 30th, 2010 | 10:44 am
[...] This post was mentioned on Twitter by Vince Humphreys. Vince Humphreys said: SHS: Cancer Gene Patent Tossed by Court: Could Have Huge Impact on Big Biotech http://bit.ly/baeHCO #tcot [...]
March 30th, 2010 | 11:58 am
This case is not directly about regenerative medicine, it is about diagnosis (and hence, the treatment that ensues).
If a patent on a human “gene” (assuming all polymorphisms fall under this category) is applied, genetic tests could not be run as you be ‘checking out’ that company’s patented product.
The courts are still behind the 8 ball in this game.
What is a gene? If one considers a “gene” to be nothing more than the guide to make a protein (yes, yes epigenetics, I know, I know), and it is really the protein that is doing the heavy lifting in the cell, what then stops the protein guide from being patented? What do I mean by protein guide? If the genetic code is redundant, which it is, one can simply make a new/different guide (gene) that will make the exact same machine (protein). Further, how do you define a gene – do you take every genetic polymorphism and say it’s off limits to patenting? Fine, what if I make a new genetic polymorphism (mutation) and use it for gene therapy or transgenic manipulation? New court challenge, separate case.
We see this in synthetic biology. You have a gene that codes for an enzyme making compound X from Y. I take that gene, change a codon or all codons, and it makes an enzyme that can make X from Y – and it may do it better than the one from nature. It may be the exact same enzyme, or it may not, depending on how I construct it. Do I have a new gene? Technically, yes. Is it found in Nature? No. Would this ruling hold up in gene therapy, then – probably not.
In the legal arena, society is running light years behind applied science in biotechnology.
The courts better fully clarify, real fast, what constitutes a “patentable” gene and what does not.
March 30th, 2010 | 2:04 pm
Mr. Smith,
a comment that has nothing to do with the content of your articles, rather the aesthetical displays: where on Earth do you find the photographs that you insert for your articles? Do you simply Google them? I ask because they are quite a variety–from serious to funny to totally kooky–I suppose it depends on the level of “kookiness” of those you are criticising. Anyway, keep doing it…I like it.
Thanks!
Emina Melonic
Wesley J. Smith Reply:
March 31st, 2010 at 2:42 pm
Emina: Thanks. That means a lot to me. I work very hard to find proper photos and illustrations to add that cherry on top to the post texts. Most come from Google images, on occasion, I use one of my own photos–which is my avocation, when I get the time. But it is almost all from Google. I type in different phrases in Google search looking for just the right image.
March 30th, 2010 | 3:38 pm
“I can’t believe I am on the same side as the ACLU …”
Why? Do you have so little regard for civil liberties?
March 30th, 2010 | 4:18 pm
Philosophical Comment Blog: Myriads of Indecency: Ruling Against Patenting Cancer Genes Makes Scientific, Legal and Ethical Sense: http://philosophicalcomment.blogspot.com/2010/03/myriads-of-indecency-ruling-against.html
March 30th, 2010 | 10:03 pm
[...] on two genes linked to an increased risk of breast and ovarian cancer. The decision by U.S. …Read Full about this medical News / resources Related Medical informationsBiotechnology ruling: Federal judge says cancer DNA in genes can't [...]
March 31st, 2010 | 1:30 pm
“I can’t believe I am on the same side as the ACLU”
YOU can’t believe it? How about US?
I have a love/hate thing with the ACLU. I would not think it possible to go too far in the defense of the Bill of Rights (which W allegedly equated to toilet paper), but about once a year or so the ACLU goes wonky on me. The worst was when they argued in favor of child molesters’ (NAMBLA) free speech rights to promote their disease. (Note to ACLU: speech in support of crime is not generally considered to be protected speech.)
For the most part, though, I believe they have the public’s interest at heart, and this is an example of that. Corporate biotech overreached here. You cannot patent what you didn’t make, or at least significantly altered. They CAN patent the processes and some of the results, and that should be enough to make them a pile of money.
March 31st, 2010 | 4:15 pm
padraig:
What if they patent a gene that has a different code but makes the same enzymatic unit? What if they make a gene that has a different code AND makes a different protein/enzymatic unit, but carries out the same function/reaction? What if they make a gene that has a different code, a different protein structure and does a new function or does the function “better” than the one in Nature? What if they pull a homolog from a, say, chimp, change it a little, and patent that – then use it in gene therapy? What about GMO’s – they take a toxic gene from microbe, stick it in a plant and the plant then kills pests – should that gene be patentable? All these scenarios are possible.
We are WAY behind here.
March 31st, 2010 | 6:13 pm
A patent implies ownership, and thus property rights. So the best case that Myriad can make is that they own the alterations. But I suggest that Myriad’s changes, while having value, are too minor in scope and too broad in application to be upheld. As with the Perfect Web Technologies, Inc. v. Infousa, Inc. Some things are too simple, obvious, and/or utilitarian to be covered under patent law.
So unless Myriad creates a new gene largely of their own design (meaning the particular sequence of base-pairs – like the arrangement of notes in a song – is mostly original) then there should be no expectation of ownership.
March 31st, 2010 | 7:15 pm
David, the key word is “make.” If they substantially alter the gene, they can probably patent it. But they can’t just grab an existing gene in situ and put a claim on it just because they’re the first ones to isolate it. Again, there are many ways for them to make a buck off this, even big bucks, without patenting nature.
In fact, it may be smarter to NOT patent it. If you patent it, you have to disclose a lot of information about it that may enable someone else to duplicate your work. Then in a few years it’s public domain anyway. Patents just give the patent holder a head start.
April 1st, 2010 | 9:11 am
Thanks for answering!
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